The Effects of Dural Puncture Epidural Versus Combined Spinal Epidural With Epidural Volume Extension Techniques on Birth Variables in Labor Analgesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ataturk University
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- First Epidural top-up time
Study Overview
Brief Summary
Labor is the process where the cervix is prepared to allow the baby to pass from the uterine cavity to the outside world. In the ordinary course, it ends with spontaneous or instrumental vaginal delivery or cesarean section. Traditionally, the first stage in which the cervix is passively dilated in response to uterine contractions consists of the second stage in which the mother passes the baby through the vagina and the third stage, the exit of the placenta.
In the first stage of labor, pain is caused by uterine contractions and pressure on the cervix. Pain is transmitted through the T10-L2 spinal nerves and is felt in the abdominal wall, waist, hips, or thighs. In the second stage, pain from the vagina and perineum is added to uterine pain. This pain is transmitted by the pudendal nerves through the S2-4 nerve roots.
In this study, we aimed to investigate the effects of dural puncture epidural analgesia versus combined spinal-epidural analgesia with epidural volume extension on labor variables.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ASA I and II parturients
- •Pregnant patients in active labor
- •active labor with cervical dilation < 5cm
- •37-42 weeks of gestational age
- •Pregnant women between the ages of 18 and 45
Exclusion Criteria
- •Patients who do not want to participate voluntarily in the study
- •Pregnant women outside the age range of 18 - 45
- •Pregnants other than Nullipar
- •Patients with allergic reactions to anesthesia and analgesia drugs to be used
- •Severe systemic disease (kidney, liver, pulmonary, endocrine, cardiac)
- •Gestational comorbidity (preeclampsia, eclampsia, diabetes mellitus, etc.)
- •Substance abuse history
- •Chronic pain history
- •Psychiatric problems and communication difficulties
- •BMI> 35 kg / m2
- •Failure in neuraxial interventions
Arms & Interventions
Dural puncture epidural
2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural
Intervention: Epidural (Drug)
Combined spinal-epidural with epidural volume extension
10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural
Intervention: Intrathecal+Epidural (Drug)
Outcomes
Primary Outcomes
First Epidural top-up time
Time Frame: First 24 hours
Time elapsed between the end of local anesthetic injection and the return of pain \>4 on the NPRS.
Secondary Outcomes
- Sacral analgesia time(First 24 hours)
- Performance time(First 24 hours)
- Incidence of Side Effect(First 24 hours)
Investigators
Muhammed E Aydin
Principal Investigator
Ataturk University